SMR Shoulder 1375.15.522Recalls & reported problems
Limacorporate SPA · SMR Shoulder - TT Augmented 360 Baseplate +2 mm; S-R; Dia.27 mm · Class 2 · Implant
All models of SMR Shoulder (67)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390267953), received between Jan 26, 2026 and Jan 26, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Loose body in joint1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 26, 2026Patient Device Interaction Problem
REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO LOOSENING. PATIENT UNDERWENT PREVIOUS SURGERY FOR A REVERSE SHOULDER AT UNKNOWN DATE. AN SMR CONSTRUCT WITH A SHORT 150MM REVERSE BODY (PART NUMBER 1352.15.005), STANDARD LINER (PART NUMBER 1360.50.810), 36MM ECCENTRICAL GLENOSPHERE (PART NUMBER 1376.09.031) AND 360° +2MM BASEPLATE (PART NUMBER 1375.15.522) WITH MEDIUM TT PEG (1375.14.652) WERE IMPLANTED AT THAT TIME. NO COMPLETE INFORMATION REGARDING ORIGINAL IMPLANT HAS BEEN PROVIDED. PATIENT REPORTED THAT THEY MOST LIKELY HAD FALLEN DURING THE YEAR. DURING VISIT, THE GLENOID COMPONENT WAS DEEMED TO BE LOOSE. REVISION SURGERY WAS THEREFORE PERFORMED AND CONFIRMED THAT ABOVE MENTIONED BASEPLATE AND SCREWS (PART NUMBER 8420.15.010) WERE LOOSE. ASSEMBLY WAS THEREFORE CONVERTED TO AN ANATOMIC CONFIGUARION REMOVING THE ABOVE-MENTIONED REVERSE HUMERAL COMPONENTS (REVERSE BODY AND LINER) AND REPLACING THEM WITH A TRAUMA HUMERAL BODY (PN 1350.15.010), AD ADAPTOR TAPER ECCENTRICAL (PN 1331.15.272) AND A 42MM HUMERAL HEAD (PN 1322.09.420). GLENOID COMPONENTS WERE REMOVED AND BONE VOID WAS FILLED WITH DEMINERALIZED BONE MATRIX AND CANCELLOUS BONE CHIPS. A SECOND SURGERY MAY BE SCHEDULED I
Patient problems: Loose body in joint
MAUDE report 24176365 ↗
Other Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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